NCT06388148

Endovascular Treatment for eXtra-Large Ischemic Stroke

Efficacy and Safety of Endovascular Thrombectomy Plus Medical Management Versus Medical Management Alone in Acute Ischemic Stroke Patients With Large Vessel Occlusion and Extra-Large Infarct Core: A Multicenter, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Zhongming Qiu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

Detailed description

Several randomized trials have shown that endovascular thrombectomy improve functional outcomes in acute ischemic stroke patients with large vessel occlusion. Recently, six randomized controlled trials demonstrated the efficacy and safety of endovascular thrombectomy for large infarct patients (defined as Alberta Stroke Program Early Computed Tomography Score \[ASPECTS\] ≥3 or infarct core \<100ml). Patients with extra-large infarct core (volume greater than 100 mL, ASPECTS score of 0 to 2) accounted for a small proportion of these trials. Therefore, the role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. That is to say, exactly where the lower limit of endovascular thrombectomy is unknown. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

Conditions

• Stroke, Acute Ischemic

Interventions

Type	Name	Description
DRUG	Medical management	Medical management includes IV thrombolysis, antiplatelet, and/or anticoagulation.
PROCEDURE	Endovascular thrombectomy	Endovascular thrombectomy with stent-retriever, local aspiration, angioplasty, and/or stenting.

Timeline

• Start date: 2024-06-16
• Primary completion: 2026-10-31
• Completion: 2027-01-31
• First posted: 2024-04-29
• Last updated: 2025-12-26

Locations

2 sites across 1 country: China